Standard Operating Procedure for Clinical Trial Material Production for Gels
1) Purpose
The purpose of this SOP is to establish procedures for the production of clinical trial materials (CTMs) for gels used in clinical trials, ensuring that materials are manufactured, labeled, stored, and distributed in compliance with Good Manufacturing Practice (GMP) guidelines and regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the pharmaceutical manufacturing facility’s clinical trial material production department, including Production Managers, Quality Assurance (QA), Regulatory Affairs, Packaging and Labeling personnel, and Clinical Operations personnel responsible for CTM production.
3) Responsibilities
Production Managers: Oversee CTM production activities and ensure adherence to SOPs and GMP guidelines.
Quality Assurance (QA): Verify compliance with GMP, review batch records, and perform quality checks on CTMs.
Regulatory Affairs: Ensure CTM production activities comply with regulatory submissions, approvals, and notifications.
Packaging and Labeling Personnel: Prepare and label CTMs according to approved protocols and regulatory requirements.
Clinical Operations: Coordinate distribution of CTMs to clinical trial sites and manage CTM inventory.
4) Procedure
4.1 Planning and Preparation
4.1.1 Initiate CTM production by defining production requirements based on clinical trial protocols and regulatory submissions.
4.1.2 Prepare a Production Plan outlining production schedules, batch sizes, and resource requirements for CTM manufacture.
4.2 Manufacturing and Packaging
4.2.1 Execute CTM production according to approved batch records and manufacturing instructions.
4.2.2 Package and label CTMs in compliance with regulatory requirements, including proper identification, batch numbering, and expiration dating.
4.3 Quality Control and Assurance
4.3.1 Perform in-process checks and quality control testing during CTM production to ensure product quality and compliance with specifications.
4.3.2 Conduct final quality assurance checks, including review of batch records and release of CTMs for distribution.
4.4 Storage and Distribution
4.4.1 Store CTMs under controlled conditions as specified in approved protocols and regulatory guidelines to maintain stability and integrity.
4.4.2 Coordinate distribution of CTMs to clinical trial sites, ensuring timely delivery and accurate documentation of shipment details.
4.5 Documentation and Reporting
4.5.1 Maintain comprehensive documentation throughout CTM production, including batch records, packaging records, labeling records, and distribution logs.
4.5.2 Report on CTM production activities, quality control results, and distribution activities to stakeholders and management as required.
5) Abbreviations, if any
SOP: Standard Operating Procedure
CTM: Clinical Trial Material
GMP: Good Manufacturing Practice
6) Documents, if any
– Production Plan
– Batch Records
– Packaging and Labeling Records
– Distribution Logs
7) Reference, if any
– FDA Guidance for Industry: Investigational New Drug Applications (INDs) — Chemistry, Manufacturing, and Controls Documentation
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– Company-specific CTM production procedures and guidelines
8) SOP Version
Version 1.0
